MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3544275
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device photo evaluation completed on (b)(6) 2020: during the visual evaluation of the picture, no apparent damage or visual anomalies were observed in the product.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.Although the product was not received, the manufacturing records of the lot-serial number provided were identified.The manufacturing records were reviewed, and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Reason for device explant and/or reoperation: reason for device explant and/or reoperation: capsular contracture (baker grade iii) manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old female who underwent breast augmentation revision with a mentor memorygel 275cc silicone prosthesis experienced bilateral capsular contracture (baker grade iii) post procedure.Through ultrasound examination, both breasts were diagnosed with baker's grade iii.As a result, bilateral replacements was performed on (b)(6) 2020.This report belong to right prosthesis.
Additional Manufacturer Narrative
Device evaluation summary completed on october 23, 2020: during the visual evaluation of the picture, no apparent damage or visual anomalies were observed in the product.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Capsular contracture complaint information is consistently analyzed and monitored by mentor quality assurance to determine when further action is necessary., according to the information reported, the patient developed capsular contracture.During visual evaluation no apparent damage or visual anomalies were observed on the returned device.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 13, 2020.The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10478130
• Report Number: 1645337-2020-10858
• Device Sequence Number: 1178663
• Product Code: FTR
• UDI-Device Identifier: 00081317001034
• UDI-Public: 00081317001034
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 3544275
• Device Catalogue Number: 3544275
• Device Lot Number: 6643946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 10/13/2020; 10/23/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/20/2020; 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR